Johnson & Johnson Reports sBLA Submission of Tremfya to the US FDA for Treating Crohn’s Disease
Shots:
- The submission is based on P-III (GALAXI) study of Tremfya (200mg, Q4W & 100mg, Q8W; SC) which includes a 48wk. P-II (GALAXI 1) dose-ranging trial & two 48wk. P-III (GALAXI 2 & GALAXI 3) confirmatory trials plus P-III (GRAVITI) study of Tremfya (400mg, SC, wks.0, 4 & 8) induction therapy for moderate to severe active Crohn’s disease
- GALAXI study reached the co-1EPs, vs PBO, across each study & showed superiority in endoscopic endpoints vs ustekinumab based on combined data from both GALAXI 2 & 3. Results were highlighted at DDW 2024
- GRAVITI study also reached the co-1EPs, depicting meaningful results in clinical remission & endoscopic response at wk.12 & attained all multiplicity-controlled endpoints vs PBO at wks.12, 24 & 48
Ref: Johnson & Johnson | Image: Johnson & Johnson
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
